Manufacturer Pfizer

Distributor Zuellig

Contents Clindamycin (Cap:HCl, Granules:palmitate HCl, Inj: phosphate)

Indications Infections caused by susceptible anaerobic or gm+ve aerobic bacteria & Chlamydia trachomatis: Upper & lower resp
tract, skin & soft tissue, bone & joint, gynecological, intra-abdominal infections, septicemia & endocarditis, dental
infection, toxoplasmic encephalitis in AIDS, Pneumocystis carinii pneumonia in AIDS, malaria. Prophylaxis of
endocarditis in patients sensitive to penicillin, infection in neck & head surgery. When used concurrently w/ an
aminoglycoside antibiotic eg gentamicin, tobramycin, it is effective in preventing peritonitis or intra-abdominal abscess
after bowel perforation & bacterial contamination secondary to trauma.
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Dosage Oral Adults 600-1800 mg/day in 2-4 equal doses. Childn >1 mth 8-25 mg/kg/day in 3-4 equal doses. IM/IV AdultSerious
infections 2400-2700 mg in 2-4 equal doses. Less complicated infections 1200-1800 mg/day in 3-4 equal doses. Childn >1
mth 20-40 mg/kg in 3-4 equal doses. Neonates <1 mth 15-20 mg/kg in 3-4 equal doses.Pelvic inflammatory disease
(inpatient treatment) Clindamycin phosphate 900 mg (IV) 8 hrly + an antibiotic w/ an appropriate gm-ve aerobic spectrum
IV. Continue w/ oral Clindamycin HCl 450-600 mg 6 hrly to complete 10-14 days total therapy. Cervicitis due
to Chlamydia trachomatis Oral Clindamycin HCl 450-600 mg qid for 10-14 days. Toxoplasmic encephalitis
in AIDS IV/Cap 600-1200 mg 6 hrly then 300-600 mg oral 6 hrly, total duration 8-10 wk. Pneumocystis
carinii pneumonia in AIDS 600-900 mg 6 hrly or 900 mg 8 hrly IV or 300-450 mg oral 6 hrly for 21 days. Acute
streptococcal tonsillitis/pharyngitis 300 mg cap bid for 10 days. Malaria Monotherapy Adult10-20 mg/kg/day. Childn 10
mg/kg/day 2 equal doses for 7 days. Prophylaxis in endocarditis in patients sensitive to penicillin Oral Given 1 hr before
surgery. Adult 600 mg. Childn 20 mg/kg. Alternatively, 600 mg IV if needed. Prophylaxis of infection in head & neck
surgery IV 900mg.
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Administration granules:Should be taken with food; cap:May be taken with or without food (Swallow whole w/ a full glass of water & in
an upright position.).

Contraindications Hypersensitivity to clindamycin or lincomycin.

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Special Precautions Pseudomembranous colitis presented as diarrhea. Perform liver & kidney function test for prolonged therapy. Fatal
"gasping syndrome" in premature infants for IV formulation due to benzyl alcohol content. Pregnancy & lactation.
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Adverse Drug Reactions Maculopapular rash, urticaria. Leukopenia & eosinophilia, agranulocytosis & thrombocytopenia. Abdominal pain,
nausea, vomiting, diarrhea. Jaundice & abnormalities in liver function test, urticaria, generalized mild to moderate
morbiliform-like skin rashes. IM: Local irritation, pain abscess formation. IV: Thrombophlebitis. Oral: Esophagitis &
esophageal ulcer.
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Drug Interactions Antagonism w/ erythromycin. Synergistic effect w/ neuromuscular blockers.

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Pregnancy Category (US

FDA)

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in
pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was
not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Description View Dalacin C description for details of the chemical structure and excipients (inactive components).

Mechanism of Action View Dalacin C mechanism of action for pharmacodynamics and pharmacokinetics details.

MIMS Class Other Antibiotics

ATC Classification J01FF01 - Clindamycin ; Belongs to the class of lincosamides. Used in the systemic treatment of infections.
Poison Schedule [?] Rx

Mechanism of Action Clindamycin is an inhibitor of protein synthesis in the bacterial cell. Depending on the sensitivity of the organisms and the
concentration of antibiotic, it may either be bactericidal or bacteriostatic. Blood levels achieved by the minimum
recommended dose (150 mg 4 times a day in adults) generally exceed the minimal bactericidal concentrations for
Staphylococci, Streptococci and Pneumococci. In clinical use, as opposed to laboratory tests, no methodology exists which
can accurately determine whether a drug's action is bactericidal or bacteriostatic in the patient.
Microbiology: Although clindamycin phosphate is inactive in vitro, rapid in vivo hydrolysis converts this compound to the
antibacterially active clindamycin. The Dalacin C spectrum of in vitro activity includes the following gram-positive aerobic
organisms: Staphylococcus aureus and Staphylococcus epidermidis (both penicillinase- and nonpenicillinase-producing
strains), streptococci (except S. faecalis), pneumococci and aerobic organisms as follows: Anaerobic gram-negative bacilli
eg, Bacteroides and Fusobacterium spp; anaerobic gram-positive nonspore-forming bacilli eg, Propionibacterium,
Eubacterium and Actinomyces spp; and anaerobic and microaerophilic gram-positive cocci
eg, Peptococcus and Peptostreptococcus spp and microaerophilic streptococci; and Clostridium sp. Dalacin C
demonstrated cross-resistance with lincomycin. When tested by in vitro methods, some staphylococcal strains originally
resistant to erythromycin rapidly developed resistance to Dalacin C.
Dalacin C sensitivity discs may be used for determination of the in vitro susceptibility of aerobic bacteria to Dalacin C.
Dalacin C sensitivity powder may be used for determination of the in vitro susceptibility of anaerobic and aerobic bacteria
to Dalacin C.
Pharmacokinetics: Dalacin C is rapidly absorbed after oral administration (peak blood levels occurred in 45 min). Bone
and other body fluid levels are obtained rapidly. Absorption is almost complete (90%), and the concomitant
administration of food does not appreciably modify the serum concentrations. Blood levels exceed the minimum inhibitory
concentration (MIC) for most gram-positive organisms for at least 6 hrs following the administration of the usually
recommended doses. The biological half-life is 2.4 hrs.
Dalacin C Phosphate: Biologically inactive clindamycin phosphate is rapidly converted to active clindamycin. By the end of
short-term IV infusion, peak serum levels of active clindamycin are reached. Biologically inactive clindamycin phosphate
disappears rapidly from the serum, the average disappearance half-life is 6 min; however, the serum disappearance half-
life of active clindamycin is about 3 hrs in adults and 2½ hrs in children.
After IM injection of clindamycin phosphate, peak levels of active clindamycin are reached within 3 hrs in adults and 1 hr
in children.
Serum levels of clindamycin can be maintained above the in vitro minimum inhibitory concentrations for most indicated
organisms by administration of clindamycin phosphate every 8-12 hrs in adults and every 6-8 hrs in children, or by
continuous IV infusion. An equilibrium state is reached by the 3rd dose.
The disappearance half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic
function; dosage schedules need not be modified in the presence of mild or moderate renal or hepatic disease. Serum
assays for active clindamycin require an inhibitor to prevent in vitro hydrolysis of clindamycin phosphate.